Feasibility Study to Investigate the Energy Expenditure of Acute Spinal Cord Injured Patients at Different Stages of Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sample size for definitive study
研究概览
简要总结
It is recognised that weight gain is a common problem in patients with a spinal cord injury and can lead to an increased incidence of metabolic syndrome. Weight gain is thought to be attributed to excess calorie intake, reduction in energy requirements and / or a reduction in exercise. However, further understanding of this energy imbalance needs to be addressed.
This feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of 15 paraplegic and 15 tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study.
详细描述
Introduction:
There are an estimated 40,000 people living with a Spinal Cord Injury (SCI) in the UK alone (http://www.apparelyzed.com/statistics.html). Although there have been improvements in medical care, mortality rates are still elevated compared to the able-bodied population. The most common underlying and contributing causes of death in SCI patients are diseases of the circulatory and respiratory system.
It is recognised that weight gain is a common problem in patients with a SCI, typically occurring within the first year of rehabilitation and continuing life long. SCI patients have been shown to have an increased fat mass, waist circumference and altered lipid profile. Obesity in SCI patients can lead to an increased incidence of metabolic syndrome.
Patient weight gain is thought to be attributed to the reduction in energy expenditure compared to pre-injury levels, the loss of voluntary muscle use below the spinal cord lesion and reduction in lean tissue mass. It has been shown that the basal metabolic rate (BMR) of SCI patients is lower than predicted, with the greatest difference being for high tetraplegics. Findings suggest there is an overestimation of energy requirements in a small population of medically stable SCI patients. In addition, SCI calorie and protein intake is high in this patient population, suggesting that patients are also exceeding their nutritional recommendations. Excess calorie intake, reduction in energy requirement and / or a reduction in exercise will predispose the SCI patient to weight gain and obesity. Further understanding of this energy imbalance needs to be addressed.
This single centre feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of paraplegic and tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study on energy expenditure and development of metabolic syndrome in SCI patients. In addition, the feasibility study will address patient recruitment rates and reasons for withdrawal from the study and highlight any practicality issues with study conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18+ years old inclusive
- •Traumatic and non-traumatic tetraplegic or paraplegic patient following acute SCI injury
- •First referral to the Sheffield Spinal Injuries Centre
- •Pressure ulcer(s) category 1 and/or 2 or normal skin
- •Be able to provide written informed consent or verbal consent in the presence of an independent witness
- •Ventilated patients without sedation
- •Enterally fed patients
排除标准
- •Aged less than 18 years old
- •Lack the mental capacity to consent
- •Pressure ulcer(s) category 3 and/or 4
- •Previously had or currently have metabolic syndrome
- •Previously had or currently have diabetes
- •Current medication includes either a stimulant(s) and/or depressant(s) e.g. steroids, anti-depressants
- •MRSA bacterium positive
- •Previously had or currently has an eating disorder
- •Ventilated patients with sedation
- •Currently participating in another research study which may have an impact on the study or patient safety and well-being.
结局指标
主要结局
Sample size for definitive study
时间窗: 1 year
Standard deviation of Resting Energy Expenditure measurements at hospital admission, initial mobilisation and hospital discharge
次要结局
- Blood Pressure Measurements(1 year)
- Dietary Intake(1 year)
- Muscle Measurements(1 year)
- Lipid Measurements(1 year)
- Adipose Tissue Measurements(1 year)
- Recruitment Period for Definitive Study(1 year)
- Predicted Energy Requirements(1 year)
- BMI Measurements(1 year)
- Glucose Measurements(1 year)